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RegisterEMEA CI on treatment, period & sequence effects [Regulatives / Guidelines]
In the most recent EMEA guideline it asks for the "tests for difference and the respective confidence intervals for the treatment effect, the period effect, and the sequence effect should be reported as descriptive data."
What exactly does this mean? How are they calculated? Can a SAS code be used to calculate the CIs on these effects.
I'm slightly confused as I thought that the confidence intervals for the difference in means between the two products to show bioequivalence would be the same as the CI for the treatment effect.
Thanks for your help in advance.
What exactly does this mean? How are they calculated? Can a SAS code be used to calculate the CIs on these effects.
I'm slightly confused as I thought that the confidence intervals for the difference in means between the two products to show bioequivalence would be the same as the CI for the treatment effect.
Thanks for your help in advance.
Complete thread:
- EMEA CI on treatment, period & sequence effectsqwerty12 2012-11-26 22:11
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- EMA: no CI on period & sequence effects Helmut 2012-11-26 22:39
- EMA: no CI on period & sequence effects qwerty12 2012-11-26 23:16
- EMA: Veterinary (!) BE Helmut 2012-11-26 23:59
- EMA: no CI on period & sequence effects qwerty12 2012-11-26 23:16
- EMA: no CI on period & sequence effects Helmut 2012-11-26 22:39
Ing. Helmut Schütz